S. 1417 — what changed

Section 1109 of the Public Health Service Act (42 U.S.C. 300b–8) is amended—

added “(5) to improve the timely collection, delivery, receipt, and screening of specimens, and the timely diagnosis of heritable disorders in newborns.”

Section 1110 of the Public Health Service Act (42 U.S.C. 300b–9) is amended—

changed “(4) methods that may be identified to improve quality in the availability diagnosis, treatment, and effectiveness disease management of follow-up care for newborns and their families after screening and diagnosis;heritable disorders based on gaps in services or care; or

changed “(5) methods or best practices by which the costs eligible entities described in section 1109 can achieve the timely collection, delivery, receipt, and effectiveness screening of newborn screening, evaluation and intervention programs, screening specimens, and surveillance systems conducted by State-based programs in order to answer issues the timely diagnosis of importance to State and national policymakers;heritable disorders in newborns.”

removed “(6) the effectiveness of newborn screening follow-up and intervention programs through the assessment of the health and development of children at school age and as young adults;

removed “(7) the level of data sharing regarding newborn screening with State-based birth defects and developmental disabilities monitoring programs;

removed “(8) the coordination of surveillance activities, including—

removed “(A) standardized data collection and reporting; and

removed “(B) use of electronic health records;

removed “(9) the facilitation of quality improvement in treatment and disease management based on gaps in services or care identified by longitudinal tracking systems; and

removed “(10) the utilization of data from longitudinal tracking systems to support the development and evaluation of evidence-based guidelines for diagnosis, treatment, and disease management.”

Section 1111 of the Public Health Service Act (42 U.S.C. 300b–10) is amended—

added “(4) provide technical assistance, as appropriate, to individuals and organizations regarding the submission of nominations to the uniform screening panel, including prior to the submission of such nominations;”

added “(L) the timely collection, delivery, receipt, and screening of specimens to be tested for heritable disorders in newborns in order to ensure rapid diagnosis and follow-up.”

added “(3) Deadline for review—For each nomination to the recommended uniform screening panel, the Advisory Committee on Heritable Disorders in Newborns and Children shall review and vote on the nominated condition within 9 months of the date on which the Advisory Committee referred the nomination to the condition review workgroup.”

removed “(4) Priority review

removed “(A) In general—For each nomination to the recommended uniform screening panel that meets the criteria of subparagraph (B), the Advisory Committee on Heritable Disorders in Newborns and Children shall provide a priority review as described in this paragraph and subject to the deadlines in subparagraph (C).

removed “(B) Criteria for priority review—The Advisory Committee on Heritable Disorders in Newborns and Children shall provide a priority review with respect to a nomination to the recommended uniform screening panel that meets each of the following criteria:

removed “(i) A human drug application, as defined in section 735(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(1)), has been submitted to the Secretary for treatment of such disease or condition.

removed “(ii) The application described in clause (i) has been granted priority review or has received fast track or breakthrough therapy designations by the Secretary as described in section 529(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff(a)(1)).

removed “(C) Deadlines for priority review—The Advisory Committee on Heritable Disorders in Newborns and Children shall vote on the nominated condition that is under priority review within 8 months of the later of—

removed “(i) the date on which the Advisory Committee refers the nomination to the condition review workgroup; or

removed “(ii) the date of the approval, by the Food and Drug Administration, of the treatment associated with the nomination to the recommended uniform screening panel.

removed “(D) Failure to act—If the Secretary fails to act on a recommendation within the time period provided for in paragraph (1), the Secretary shall adopt the recommendation and include the screening recommended by the Advisory Committee on Heritable Disorders in Newborns and Children in the recommended uniform screening panel.

removed “(E) Other reviews—For each nomination to the recommended uniform screening panel that does not meet the criteria of subparagraph (B), the Advisory Committee on Heritable Disorders in Newborns and Children shall provide for a review and vote on the nominated condition that is under review within 10 months of the date on which the Advisory Committee referred the nomination to the condition review workgroup.”

changed “(f) Meetings—The Advisory Committee shall meet at least 4 times each calendar year with at least 2 meetings year, or as subject to the discretion of the Designated Federal Officer in person.”consultation with the Chair.”

Section 1112 of the Public Health Service Act (42 U.S.C. 300b–11) is amended—

changed “(4) maintain current data information on the number of conditions for which screening is conducted in each State; and

changed “(5) disseminate available evidence-informed evidence-based guidelines related to diagnosis, counseling, and treatment with respect to conditions detected by newborn screening.”

Section 1113 of the Public Health Service Act (42 U.S.C. 300b–12) is amended—

added “(b) Surveillance activities—The Secretary, acting through the Director of the Centers for Disease Control and Prevention, and taking into consideration the expertise of the Advisory Committee on Heritable Disorders in Newborns and Children established under section 1111, may provide, as appropriate, for the coordination of surveillance activities, including—

added “(1) through standardized data collection and reporting, as well as the use of electronic health records; and

added “(2) by promoting data sharing regarding newborn screening with State-based birth defects and developmental disabilities monitoring programs.”

Section 1114 of the Public Health Service Act (42 U.S.C. 300b–13) is amended—

removed “(e) Report to congress

removed “(1) In general—The Secretary shall—

removed “(A) not later than 1 year after the date of enactment of the Newborn Screening Saves Lives Reauthorization Act of 2013, submit to the Health, Education, Labor, and Pensions Committee of the Senate and the Energy and Commerce Committee of the House of Representatives a report on activities related to—

removed “(i) newborn screening; and

removed “(ii) screening children who have or are at risk for heritable disorders; and

removed “(B) not less than every 2 years, shall submit to such committees an updated version of such report.

removed “(2) Contents—The report submitted under subsection (a) shall contain a description of—

removed “(A) the implementation of sections 1111 through 1116B, including this section; and

removed “(B) the amounts expended on such implementation.”

Section 1116(a)(1) of the Public Health Service Act (42 U.S.C. 300b–15(a)(1)) is amended—

changed “(C) by providing research findings and data for newborn conditions under review by the Advisory Committee on Heritable Disorders in Newborns and Children to be added to the recommended uniform screening panel;

“(D) conducting pilot studies on conditions recommended by the Advisory Committee on Heritable Disorders in Newborns and Children to ensure that screenings are ready for nationwide implementation; and”